Yasuko Maeda

Suboptimal outcome following sacral nerve stimulation for faecal incontinence

The aim of the study was to identify the incidence of suboptimal therapeutic responses and adverse events associated with sacral nerve stimulation (SNS) for faecal incontinence, and to determine their influence on treatment outcome.

Pilot study of two new injectable bulking agents for the treatment of faecal incontinence

Objective  The use of injectable bulking agents for passive faecal incontinence appears to provide reasonable short‐term results. However experience with different agents is limited. We report on the outcome of injections with new bulking agents.

Long-term results of perianal silicone injection for faecal incontinence

Objective  Perianal injection of bulking agents is a simple method for treating passive faecal incontinence. To date only short‐term results of treatment are available. This study is the first to determine the efficacy of silicone biomaterial (PTQTM; Uroplasty BV, Geleen, The Netherlands) injection in the long term.

Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease†

The potential for metronidazole 10 per cent ointment to exert therapeutic benefit in perianal Crohns disease, while minimizing the adverse effects found with oral metronidazole, was evaluated in a randomized placebo‐controlled study.

Outcome of sacral nerve stimulation for fecal incontinence at 5 years.

Objective:This study aimed to evaluate the outcome of sacral nerve stimulation (SNS) for fecal incontinence at 5 years after implantation and to identify predictors of sustained efficacy. Background:There is a lack of knowledge about the long-term outcome of SNS for fecal incontinence. Methods:Prospectively collected data from patients who underwent implantation of an SNS device between 2001 and 2006 were reviewed. Results:One hundred and one patients were available for outcome evaluation at 5 years. Sixty of 101 patients [42.6% on intention-to-treat (ITT) and 55.6% per protocol (PP)] reported a favorable outcome, 41 patients (ITT 29.1%; PP 38.0%) reported an unfavorable outcome, of whom 24 patients (ITT 17.0%; PP 22.2%) had their device explanted or permanently switched off before 5 years. Wexner incontinence scores improved significantly from a baseline median of 16 (range 6–20) to a median of 6 (range 0–20) at 3 months (P < 0.0001), and the improvement compared with baseline was maintained throughout the 5-year follow-ups (P < 0.0001).Age was a negative predictive factor [odds ratio (OR): 0.96 each year increase, 95% confidence interval (CI): 0.92–0.99; P = 0.016]. Positive predictors included improvement of urge incontinence episodes during percutaneous nerve evaluation (OR: 10.8; 95% CI: 1.72–132; P = 0.036), improvement of incontinence scores at 6 months from baseline (OR: 6.29; 95% CI: 1.33–34.3; P = 0.025), particularly improvement of incontinence scores from 3 to 6 months (OR: 41.5; 95% CI: 3.51–811; P = 0.007). Overall, 521 reportable events were recorded from 94 patients (93.1%). Conclusions:On an ITT analysis, 42.6% of patients reported favorable outcomes at 60 months. Patients age, improvement of urge incontinence during PNE, and sustained efficacy during the first 6 months after implantation are some of the predictors identified.

Postoperative Issues of Sacral Nerve Stimulation for Fecal Incontinence and Constipation: A Systematic Literature Review and Treatment Guideline

BACKGROUND: There is a lack of knowledge on the incidence and management of suboptimal therapeutic effect and the complications associated with sacral nerve stimulation for fecal incontinence and constipation. OBJECTIVE: This study aimed to review current literature on postoperative issues and to propose a treatment algorithm. DATA SOURCE: PubMed, MEDLINE, and EMBASE were searched using the keywords “sacral nerve stimulation,” “sacral neuromodulation,” “fecal incontinence,” and “constipation” for English-language articles published from January 1980 to August 2010. A further search was conducted on a wider literature using the keywords “complication,” “adverse effect,” “treatment failure,” “equipment failure,” “infection,” “foreign-body migration,” “reoperation,” “pain,” and “algorithm.” STUDY SELECTION: Four hundred sixty-one titles were identified, and after a title and abstract review, 135 were subjected to full article review; 89 were finally included in this review. Five articles were added by manual search and consensus. RESULTS: Forty-eight studies were identified as cohort studies reporting on postoperative issues, including 1661 patients who underwent percutaneous nerve evaluation and 1600 patients who proceeded to sacral nerve stimulation therapy. Pooled data showed that the most common problem during percutaneous nerve evaluation was lead displacement (5.3%). The incidence of suboptimal outcome, pain, and infection after implantation was 12.1%, 13.0%, and 3.9%. LIMITATIONS: There was significant underreporting of untoward events, because 60% of the studies did not report complications during percutaneous nerve evaluation, and suboptimal outcome after implantation was not disclosed in 44% of the studies. CONCLUSIONS: The incidence of untoward events associated with sacral nerve stimulation appears to be low. However, there is a significant underreporting of the incidence. Using the information from the structured and systematic literature review, we formulated a clinically relevant guideline for reporting and managing postoperative issues. The guideline can provide a framework for clinical practice.

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement.

In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation.

Predictors of the outcome of percutaneous nerve evaluation for faecal incontinence

The aim was to identify patient‐related and operative factors that might predict the outcome of percutaneous nerve evaluation (PNE).

Medium-term outcome of sacral nerve modulation for constipation

BACKGROUND: Sacral nerve modulation has been reported as a minimally invasive and effective treatment for constipation refractory to conservative treatment. OBJECTIVE: This study aimed to evaluate the efficacy and sustainability of sacral nerve modulation for constipation in the medium term (up to 6 years) and to investigate potential predictors of treatment success. DESIGN: We performed a retrospective review of prospectively collected data. SETTINGS: The study was performed at 2 tertiary-care centers in Europe with expertise in pelvic floor disorders and sacral nerve modulation. PATIENTS: Patients were eligible if they had had symptoms of constipation persisting for at least 1 year, if conservative treatment (dietary modification, laxatives and biofeedback therapy) had failed, and if predefined excluded conditions were not present. INTERVENTION: The first phase of the treatment process was percutaneous nerve evaluation. If this was successful, patients underwent sacral nerve modulation therapy with an implanted device (tined-lead and implantable pulse generator). MAIN OUTCOME MEASURE: Follow-up was performed at 1, 3, 6, and 12 months, and yearly thereafter. Outcome was assessed with the Wexner constipation score. RESULTS: A total of 117 patients (13 men, 104 women) with a mean age of 45.6 (SD, 13.0) years underwent percutaneous nerve evaluation. Of these, 68 patients (58%) had successful percutaneous nerve evaluation and underwent implantation of a device. The mean Wexner score was 17.0 (SD, 3.8) at baseline and 10.2 (SD 5.3) after percutaneous nerve evaluation (p < .001); the improvement was maintained throughout the follow-up period, although the number of patients continuing with sacral nerve modulation at the latest follow-up (median, 37 months; range, 4–92) was only 61 (52% of all patients who underwent percutaneous nerve evaluation). The sole predictive factor of outcome of percutaneous nerve evaluation was age: younger patients were more likely than older patients to have a successful percutaneous nerve evaluation phase. LIMITATIONS: The study was limited by a lack of consistent outcome measures. CONCLUSIONS: Despite improvement in Wexner scores, at the latest follow-up sacral nerve modulation was only being used by slightly more than 50% of the patients who started the first phase of treatment. Further studies are needed to reassess the efficacy and sustainability of sacral nerve modulation.

Percutaneous tibial nerve stimulation for slow transit constipation: a pilot study

Aim  Chronic constipation is a problem with debilitating effects on patients’ quality of life. This study aimed to evaluate the effectiveness of percutaneous tibial nerve stimulation in patients with slow transit constipation.